MINIject in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

Not Applicable

Completed

• Conditions: Open Angle Glaucoma
• Interventions: Device: MINIject implant

• Registration Number: NCT03193736
• Lead Sponsor: iSTAR Medical

Brief Summary

The study will evaluate the efficacy and safety of the implant and intra-ocular pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-09
• Study Start: 2017-06-19
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-21
• Primary Completion: 2018-04-16
• Study Completion: 2019-11-25
• Results First Submitted: 2020-12-21
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Results First Posted: 2021-02-17
• Last Update Posted: 2021-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
• Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.
• Glaucoma not adequately controlled

Exclusion Criteria

• Diagnosis of glaucoma other than open angle glaucoma
• Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System.
• Neovascular glaucoma in the study eye
• Prior glaucoma surgery in the study eye
• Clinically significant corneal disease
• Patients with poor vision

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
implant	MINIject implant	-

Primary Outcome Measures

Name	Time	Method
Change in Medicated Diurnal Intra-ocular Pressure (IOP) at 6 Months Post-implantation	6 months after implantation surgery	Change of Medicated diurnal IOP \[mmHg\] from pre-implantation Baseline to 6 months post-implantation, with or without the use of the allowed concomitant glaucoma hypotensive medication

Trial Locations

Locations (2)

Clinica de ojos Orillac-Calvo; 🇵🇦 Panama city, Panama

Maxivision Eye Hospital; 🇮🇳 Hyderabad, Telangana, India